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Theranova 400 Dialyzer In End Stage Renal Disease (ESRD) Patients

End Stage Renal Disease Clinical Trial

Official title:
A Multi-Center, Prospective, Randomized, Controlled, Open-label, Parallel Study to Evaluate the Safety and Efficacy of the Theranova 400 Dialyzer In End Stage Renal Disease (ESRD) Patients

Clinical Trial Summary

The study evaluates the efficacy and safety of the Theranova 400 dialyzer compared with Elisio-17 H dialyzer in end stage renal disease patients receiving hemodialysis treatment. Efficacy will be determined by the removal of middle molecules (with different molecular size) from the blood compartment. Safety will be evaluated by maintaining pre-dialysis serum albumin levels and other safety events including laboratory tests and adverse events. Patients will undergo 3 dialysis sessions per week, for 24 weeks.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03257410
Study type Interventional
Source Baxter Healthcare Corporation
Contact
Status Completed
Phase N/A
Start date September 29, 2017
Completion date October 27, 2018
View Details
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